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A Study for Patients With Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00415194
Recruitment Status : Completed
First Posted : December 22, 2006
Results First Posted : April 6, 2011
Last Update Posted : June 28, 2011
Sponsor:
Information provided by:
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Head and Neck Neoplasms
Interventions Drug: pemetrexed
Drug: cisplatin
Drug: placebo
Enrollment 795
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pemetrexed/Cisplatin Placebo/Cisplatin
Hide Arm/Group Description

Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.

Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.

Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.

Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.

Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.

Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.

Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.

Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.

Period Title: Overall Study
Started 398 397
Received at Least 1 Dose of Study Drug 392 385
Completed 70 55
Not Completed 328 342
Reason Not Completed
Adverse Event             37             32
Entry Criteria Not Met             4             8
Lost to Follow-up             1             0
Physician Decision             10             16
Progressive Disease             180             217
Protocol Violation             4             2
Withdrawal by Subject             28             21
Death Due to Study Disease             26             29
Death Due to Study Drug Related AE             11             1
Death Due to Procedural Related AE             0             1
Death Due to AE (Other Causes)             27             15
Arm/Group Title Pemetrexed/Cisplatin Placebo/Cisplatin Total
Hide Arm/Group Description

Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.

Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.

Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.

Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.

Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.

Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.

Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.

Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.

Total of all reporting groups
Overall Number of Baseline Participants 398 397 795
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 398 participants 397 participants 795 participants
57.45  (9.54) 57.78  (9.36) 57.62  (9.44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 398 participants 397 participants 795 participants
Female
56
  14.1%
53
  13.4%
109
  13.7%
Male
342
  85.9%
344
  86.6%
686
  86.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 398 participants 397 participants 795 participants
African 17 12 29
Caucasian 243 233 476
East Asian 55 65 120
Hispanic 11 16 27
West Asian (Indian sub-continent) 72 70 142
Unknown 0 1 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 398 participants 397 participants 795 participants
Argentina 5 10 15
Belgium 7 10 17
Brazil 16 12 28
China 5 7 12
Denmark 7 3 10
France 3 3 6
Germany 50 48 98
Hungary 23 22 45
India 72 75 147
Italy 19 21 40
Korea, Republic of 29 24 53
Mexico 9 8 17
Netherlands 8 11 19
Poland 10 10 20
Romania 20 22 42
Russian Federation 23 20 43
South Africa 11 9 20
Spain 31 29 60
Taiwan 21 25 46
United States 29 28 57
Previously Treated for Head and Neck Cancer (HNC)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 398 participants 397 participants 795 participants
No 35 39 74
Yes 363 358 721
Prior Treatment with Platinum-Based Therapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 398 participants 397 participants 795 participants
No 213 228 441
Yes 185 169 354
Distant Metastasis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 398 participants 397 participants 795 participants
No 165 155 320
Yes 233 242 475
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 398 participants 397 participants 795 participants
0 90 90 180
1 257 253 510
2 51 53 104
Missing Data 0 1 1
[1]
Measure Description:

These scales and criteria are used by doctors and researchers to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis:

  1. Fully active, able to carry on all pre-disease performance without restriction
  2. Restricted in strenuous activity,able to carry out work of a light or sedentary nature
  3. Ambulatory, but unable to carry out any work activities. Capable of only limited selfcare
  4. Completely disabled. Cannot carry on any selfcare.
  5. Dead
Primary Site of Disease  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 398 participants 397 participants 795 participants
Hypopharynx 63 59 122
Larynx 103 102 205
Oral Cavity 138 123 261
Oropharynx 86 106 192
Other 8 7 15
1.Primary Outcome
Title Overall Survival (OS)
Hide Description OS duration is defined as the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data-inclusion cut-off date, OS duration will be censored at the date of the participant’s last contact prior to that cut-off date.
Time Frame Baseline to date of death from any cause up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) Population - defines the treatment group as those to which participants were assigned by random allocation, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol.
Arm/Group Title Pemetrexed/Cisplatin Placebo/Cisplatin
Hide Arm/Group Description:

Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.

Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.

Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.

Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.

Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.

Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.

Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.

Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.

Overall Number of Participants Analyzed 398 397
Median (95% Confidence Interval)
Unit of Measure: Months
7.33
(6.34 to 8.38)
6.28
(5.52 to 7.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pemetrexed/Cisplatin, Placebo/Cisplatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.082
Comments [Not Specified]
Method Stratified Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.75 to 1.02
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description Objective PFS is defined as the time from date of randomization to date of objectively determined progressive disease (PD) or death from any cause, whichever comes first. PD was defined by Response Evaluation Criteria in Solid Tumors (RECIST). PD=at least a 20% increase in sum of longest diameter of target lesions. For participants who are not known to have died as of the data-inclusion cut-off date, and who do not have progressive disease, PFS will be censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systemic anticancer therapy.
Time Frame baseline to measured progressive disease up to 33 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) Population - defines the treatment group as those to which participants were assigned by random allocation, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol.
Arm/Group Title Pemetrexed/Cisplatin Placebo/Cisplatin
Hide Arm/Group Description:

Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.

Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.

Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.

Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.

Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.

Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.

Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.

Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.

Overall Number of Participants Analyzed 398 397
Median (95% Confidence Interval)
Unit of Measure: months
3.61
(3.15 to 4.07)
2.79
(2.69 to 3.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pemetrexed/Cisplatin, Placebo/Cisplatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.166
Comments [Not Specified]
Method Stratified Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.76 to 1.03
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percent of Participants With a Tumor Response (Response Rate)
Hide Description Tumor Response is evaluated as CR (Complete Response) or PR (Partial Response) per Response Evaluation Criteria in Solid Tumors (RECIST criteria). Possible evaluations include: CR: Disappearance of all target lesions. PR: At least a 30% decrease in the size of target lesions. Response rate (%) = (number of participants with CR+PR/number of participants)*100
Time Frame Baseline to progressive disease or discontinuation of study treatment up to 11 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT) Population - defines the treatment group as those to which participants were assigned by random allocation, even if a participant did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol.
Arm/Group Title Pemetrexed/Cisplatin Placebo/Cisplatin
Hide Arm/Group Description:

Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.

Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.

Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.

Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.

Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.

Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.

Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.

Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.

Overall Number of Participants Analyzed 398 397
Measure Type: Number
Unit of Measure: Percentage of participants
12.1 8.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pemetrexed/Cisplatin, Placebo/Cisplatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.061
Comments [Not Specified]
Method Unadjusted normal distribution
Comments p-value is based on an unadjusted, normal distribution approximation for differences in rates.
4.Secondary Outcome
Title Duration of Response (DoR)
Hide Description DoR is time from first observation of complete response (CR) or partial response (PR) to first observation of PD or death. Response is objective status of CR or PR using RECIST criteria. CR is disappearance of lesions. PR is >30% decrease in size of lesions. Responder is any participant with CR or PR. PD is at least 20% increase in sum of longest diameter of target lesions. For participants alive as of data-inclusion cut-off date and who do not have PD, DoR will be censored at date of last objective progression-free disease assessment before date of any subsequent systemic anticancer therapy.
Time Frame time of response to progressive disease up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population with a confirmed best response of complete response (CR) or partial response (PR).
Arm/Group Title Pemetrexed/Cisplatin Placebo/Cisplatin
Hide Arm/Group Description:

Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.

Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.

Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.

Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.

Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.

Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.

Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.

Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.

Overall Number of Participants Analyzed 48 32
Median (95% Confidence Interval)
Unit of Measure: Months
5.29
(4.21 to 5.98)
4.37
(3.58 to 6.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pemetrexed/Cisplatin, Placebo/Cisplatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.811
Comments [Not Specified]
Method Stratified Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.56 to 1.53
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Time to Treatment Worsening in Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Total Score
Hide Description FACT-H&N consists of 39 items with 5-point rating scale from 0 (not at all) to 4 (very much). FACT-H&N Total score ranges from 0 to 148. Higher score represents a better quality of life. Time to worsening was defined as the first date of worsening in the FACT H&N Total score that was considered at least the prospectively defined minimally important difference (MID) as compared with participant’s baseline score, or date of death from any cause. The MID for FACT H&N Total score was a decrease of 12 points.
Time Frame Baseline (</=Day 1 of first dose) and Day 1 of every subsequent cycle to 30-day post-study completion up to 33 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population with at least Baseline data.
Arm/Group Title Pemetrexed/Cisplatin Placebo/Cisplatin
Hide Arm/Group Description:

Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.

Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.

Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.

Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.

Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.

Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.

Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.

Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.

Overall Number of Participants Analyzed 271 270
Median (95% Confidence Interval)
Unit of Measure: Months
3.29
(2.76 to 4.11)
2.89
(2.40 to 3.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pemetrexed/Cisplatin, Placebo/Cisplatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
Comments [Not Specified]
Method Stratified Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.69 to 1.07
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Correlation Between Biomarkers and Treatment Effect
Hide Description

Correlation between highly up/downregulated genes and clinical response (Overall Survival (OS) and Progression-Free Survival (PFS)). OS is is defined as the time from the date of randomization to the date of death from any cause. PFS is defined as the time from the date of randomization to the date of objectively determined progressive disease or death from any cause, whichever comes first.

0 participants were analyzed; Reason: The relatively low number of samples collected would not have yielded a meaningful genomic analysis and the decision was made to not analyze the data.

Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants were analyzed because the relatively low number of samples collected would not have yielded a meaningful genomic analysis.
Arm/Group Title Pemetrexed/Cisplatin Placebo/Cisplatin
Hide Arm/Group Description:

Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.

Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.

Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.

Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.

Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.

Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.

Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.

Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Participants who received at least one dose of study drug were included in the safety population included here.
 
Arm/Group Title Pemetrexed/Cisplatin Placebo/Cisplatin
Hide Arm/Group Description Pemetrexed 500 milligrams per meter square (mg/m2) administered intravenously (IV) plus cisplatin 75 mg/m2 IV on Day 1 every 21 days. Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose. Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m2 on Day 1 every 21 days. Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.
All-Cause Mortality
Pemetrexed/Cisplatin Placebo/Cisplatin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pemetrexed/Cisplatin Placebo/Cisplatin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   185/392 (47.19%)      132/385 (34.29%)    
Blood and lymphatic system disorders     
Agranulocytosis  1  3/392 (0.77%)  6 0/385 (0.00%)  0
Anaemia  1  22/392 (5.61%)  27 17/385 (4.42%)  20
Anaemia of malignant disease  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Bone marrow toxicity  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Febrile neutropenia  1  12/392 (3.06%)  13 0/385 (0.00%)  0
Leukopenia  1  14/392 (3.57%)  16 1/385 (0.26%)  1
Lymphadenitis  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Neutropenia  1  12/392 (3.06%)  13 3/385 (0.78%)  3
Thrombocytopenia  1  11/392 (2.81%)  12 3/385 (0.78%)  3
Cardiac disorders     
Acute myocardial infarction  1  3/392 (0.77%)  3 0/385 (0.00%)  0
Atrial fibrillation  1  2/392 (0.51%)  2 0/385 (0.00%)  0
Atrial flutter  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Cardiac arrest  1  2/392 (0.51%)  2 0/385 (0.00%)  0
Cardiac failure  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Cardio-respiratory arrest  1  2/392 (0.51%)  2 1/385 (0.26%)  1
Cardiopulmonary failure  1  3/392 (0.77%)  3 2/385 (0.52%)  2
Myocardial infarction  1  1/392 (0.26%)  1 2/385 (0.52%)  2
Myocardial ischaemia  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Congenital, familial and genetic disorders     
Tracheo-oesophageal fistula  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Ear and labyrinth disorders     
Deafness  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Tinnitus  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Vertigo  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  2/392 (0.51%)  4 1/385 (0.26%)  1
Aphagia  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Constipation  1  4/392 (1.02%)  4 2/385 (0.52%)  2
Diarrhoea  1  14/392 (3.57%)  14 1/385 (0.26%)  1
Disbacteriosis  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Duodenal ulcer  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Duodenal ulcer haemorrhage  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Duodenal ulcer perforation  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Dysphagia  1  6/392 (1.53%)  6 3/385 (0.78%)  3
Gastric ulcer haemorrhage  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Gastric ulcer perforation  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Gastritis  1  1/392 (0.26%)  2 0/385 (0.00%)  0
Gastrointestinal haemorrhage  1  1/392 (0.26%)  1 1/385 (0.26%)  1
Gastrointestinal necrosis  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Gastrooesophageal reflux disease  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Glossodynia  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Haematemesis  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Ileus  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Intestinal infarction  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Mesenteric artery thrombosis  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Mouth haemorrhage  1  2/392 (0.51%)  2 2/385 (0.52%)  3
Nausea  1  13/392 (3.32%)  14 7/385 (1.82%)  7
Oesophageal stenosis  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Oesophagitis  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Peritonitis  1  2/392 (0.51%)  2 0/385 (0.00%)  0
Stomatitis  1  2/392 (0.51%)  2 0/385 (0.00%)  0
Tongue oedema  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Vomiting  1  22/392 (5.61%)  24 9/385 (2.34%)  9
General disorders     
Adhesion  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Asthenia  1  6/392 (1.53%)  8 9/385 (2.34%)  9
Chest pain  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Chills  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Death  1  4/392 (1.02%)  4 4/385 (1.04%)  4
Face oedema  1  1/392 (0.26%)  1 1/385 (0.26%)  1
Fatigue  1  7/392 (1.79%)  7 5/385 (1.30%)  5
General physical health deterioration  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Influenza like illness  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Local swelling  1  1/392 (0.26%)  1 1/385 (0.26%)  1
Localised oedema  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Malaise  1  1/392 (0.26%)  1 1/385 (0.26%)  1
Mucosal inflammation  1  1/392 (0.26%)  1 1/385 (0.26%)  1
Multi-organ failure  1  1/392 (0.26%)  1 1/385 (0.26%)  1
Oedema peripheral  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Pain  1  0/392 (0.00%)  0 2/385 (0.52%)  2
Performance status decreased  1  2/392 (0.51%)  2 0/385 (0.00%)  0
Pyrexia  1  9/392 (2.30%)  9 6/385 (1.56%)  7
Sudden cardiac death  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis acute  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Hepatic failure  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Immune system disorders     
Hypersensitivity  1  0/392 (0.00%)  0 2/385 (0.52%)  2
Infections and infestations     
Abdominal infection  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Abdominal wall abscess  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Abscess  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Acinetobacter infection  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Bronchitis  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Bronchopneumonia  1  2/392 (0.51%)  2 0/385 (0.00%)  0
Candida sepsis  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Catheter site infection  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Cellulitis  1  1/392 (0.26%)  1 1/385 (0.26%)  1
Central line infection  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Empyema  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Gastroenteritis  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Gastrointestinal infection  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Herpes zoster  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Infection  1  1/392 (0.26%)  1 3/385 (0.78%)  3
Lower respiratory tract infection  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Lung infection  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Oral candidiasis  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Oral infection  1  2/392 (0.51%)  2 0/385 (0.00%)  0
Pneumonia  1  26/392 (6.63%)  29 7/385 (1.82%)  9
Pseudomonal sepsis  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Pseudomonas infection  1  0/392 (0.00%)  0 1/385 (0.26%)  2
Pulmonary tuberculosis  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Respiratory tract infection  1  1/392 (0.26%)  1 1/385 (0.26%)  1
Sepsis  1  4/392 (1.02%)  4 4/385 (1.04%)  4
Septic shock  1  3/392 (0.77%)  3 2/385 (0.52%)  2
Skin infection  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Staphylococcal infection  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Staphylococcal sepsis  1  2/392 (0.51%)  2 0/385 (0.00%)  0
Superinfection bacterial  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Tracheitis  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Urinary tract infection  1  1/392 (0.26%)  1 1/385 (0.26%)  1
Wound infection  1  0/392 (0.00%)  0 2/385 (0.52%)  2
Injury, poisoning and procedural complications     
Femoral neck fracture  1  2/392 (0.51%)  2 1/385 (0.26%)  1
Femur fracture  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Gastrointestinal stoma complication  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Gastrostomy failure  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Humerus fracture  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Post procedural haemorrhage  1  1/392 (0.26%)  2 3/385 (0.78%)  3
Thoracic vertebral fracture  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Tracheal obstruction  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Investigations     
Aspiration bronchial  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Blood alkaline phosphatase increased  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Blood creatinine increased  1  4/392 (1.02%)  4 1/385 (0.26%)  1
Blood electrolytes abnormal  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Blood pressure increased  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Creatinine renal clearance decreased  1  1/392 (0.26%)  1 2/385 (0.52%)  2
ECG signs of myocardial ischaemia  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Glomerular filtration rate decreased  1  1/392 (0.26%)  1 1/385 (0.26%)  1
Haemoglobin decreased  1  7/392 (1.79%)  9 4/385 (1.04%)  4
Lymphocyte count decreased  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Neutrophil count decreased  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Platelet count decreased  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Weight decreased  1  3/392 (0.77%)  3 0/385 (0.00%)  0
White blood cell count decreased  1  1/392 (0.26%)  1 0/385 (0.00%)  0
White blood cell count increased  1  2/392 (0.51%)  2 0/385 (0.00%)  0
Metabolism and nutrition disorders     
Anorexia  1  5/392 (1.28%)  5 5/385 (1.30%)  6
Cachexia  1  2/392 (0.51%)  2 0/385 (0.00%)  0
Decreased appetite  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Dehydration  1  9/392 (2.30%)  9 7/385 (1.82%)  7
Diabetic foot  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Hypercalcaemia  1  1/392 (0.26%)  1 2/385 (0.52%)  2
Hyperglycaemia  1  1/392 (0.26%)  1 1/385 (0.26%)  1
Hyperkalaemia  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Hypocalcaemia  1  1/392 (0.26%)  2 2/385 (0.52%)  2
Hypokalaemia  1  6/392 (1.53%)  7 7/385 (1.82%)  7
Hypomagnesaemia  1  1/392 (0.26%)  1 2/385 (0.52%)  3
Hyponatraemia  1  9/392 (2.30%)  9 5/385 (1.30%)  5
Hypophagia  1  2/392 (0.51%)  2 0/385 (0.00%)  0
Hypovolaemia  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Shock hypoglycaemic  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Back pain  1  1/392 (0.26%)  1 1/385 (0.26%)  1
Musculoskeletal chest pain  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Myalgia  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Neck pain  1  0/392 (0.00%)  0 2/385 (0.52%)  2
Osteoarthritis  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Trismus  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer pain  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Infected neoplasm  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Intracranial tumour haemorrhage  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Metastases to bone  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Metastatic pain  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Oncologic complication  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Skin neoplasm bleeding  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Tumour haemorrhage  1  1/392 (0.26%)  1 4/385 (1.04%)  6
Tumour pain  1  4/392 (1.02%)  4 1/385 (0.26%)  1
Nervous system disorders     
Anoxic encephalopathy  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Cerebral infarction  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Cerebral ischaemia  1  2/392 (0.51%)  2 1/385 (0.26%)  1
Cerebrovascular accident  1  1/392 (0.26%)  1 1/385 (0.26%)  1
Coma  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Convulsion  1  0/392 (0.00%)  0 3/385 (0.78%)  3
Dizziness  1  1/392 (0.26%)  1 1/385 (0.26%)  1
Encephalitis  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Hydrocephalus  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Lethargy  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Loss of consciousness  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Polyneuropathy  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Spinal cord compression  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Syncope  1  3/392 (0.77%)  4 4/385 (1.04%)  4
Psychiatric disorders     
Depression  1  2/392 (0.51%)  2 0/385 (0.00%)  0
Disorientation  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Psychotic disorder  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Suicidal ideation  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Suicide attempt  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Renal and urinary disorders     
Renal failure  1  7/392 (1.79%)  9 4/385 (1.04%)  5
Renal failure acute  1  3/392 (0.77%)  4 2/385 (0.52%)  2
Renal impairment  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  1/392 (0.26%)  1 1/385 (0.26%)  1
Bronchial secretion retention  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Cough  1  2/392 (0.51%)  2 1/385 (0.26%)  1
Dyspnoea  1  10/392 (2.55%)  10 15/385 (3.90%)  15
Haemoptysis  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Hypoxia  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Laryngeal dyspnoea  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Laryngeal oedema  1  4/392 (1.02%)  4 0/385 (0.00%)  0
Lung infiltration  1  2/392 (0.51%)  2 0/385 (0.00%)  0
Pharyngeal stenosis  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Pneumonia aspiration  1  2/392 (0.51%)  2 1/385 (0.26%)  1
Pneumonitis  1  2/392 (0.51%)  2 1/385 (0.26%)  1
Pneumothorax  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Pulmonary embolism  1  2/392 (0.51%)  2 1/385 (0.26%)  1
Pulmonary oedema  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Respiratory distress  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Respiratory failure  1  2/392 (0.51%)  2 2/385 (0.52%)  2
Respiratory tract haemorrhage  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Rhinorrhoea  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Stridor  1  0/392 (0.00%)  0 2/385 (0.52%)  2
Upper airway obstruction  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Skin and subcutaneous tissue disorders     
Angioedema  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Skin ulcer  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Subcutaneous emphysema  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Swelling face  1  1/392 (0.26%)  1 1/385 (0.26%)  1
Vascular disorders     
Circulatory collapse  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Deep vein thrombosis  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Embolism  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Femoral artery occlusion  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Haemodynamic instability  1  0/392 (0.00%)  0 1/385 (0.26%)  1
Haemorrhage  1  1/392 (0.26%)  1 3/385 (0.78%)  3
Hypotension  1  4/392 (1.02%)  4 1/385 (0.26%)  2
Orthostatic hypotension  1  2/392 (0.51%)  2 0/385 (0.00%)  0
Peripheral ischaemia  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Phlebitis  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Shock  1  1/392 (0.26%)  1 1/385 (0.26%)  1
Shock haemorrhagic  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Subclavian vein thrombosis  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Superior vena caval occlusion  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Venous thrombosis  1  1/392 (0.26%)  1 0/385 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pemetrexed/Cisplatin Placebo/Cisplatin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   343/392 (87.50%)      316/385 (82.08%)    
Blood and lymphatic system disorders     
Anaemia  1  118/392 (30.10%)  133 79/385 (20.52%)  88
Leukopenia  1  38/392 (9.69%)  57 24/385 (6.23%)  35
Neutropenia  1  67/392 (17.09%)  105 35/385 (9.09%)  48
Thrombocytopenia  1  28/392 (7.14%)  33 17/385 (4.42%)  22
Gastrointestinal disorders     
Constipation  1  56/392 (14.29%)  63 53/385 (13.77%)  65
Diarrhoea  1  42/392 (10.71%)  50 33/385 (8.57%)  35
Dysphagia  1  19/392 (4.85%)  19 22/385 (5.71%)  23
Nausea  1  118/392 (30.10%)  199 106/385 (27.53%)  153
Vomiting  1  62/392 (15.82%)  81 79/385 (20.52%)  104
General disorders     
Asthenia  1  36/392 (9.18%)  41 31/385 (8.05%)  35
Fatigue  1  67/392 (17.09%)  88 53/385 (13.77%)  57
Mucosal inflammation  1  25/392 (6.38%)  30 8/385 (2.08%)  8
Pain  1  16/392 (4.08%)  19 20/385 (5.19%)  23
Pyrexia  1  40/392 (10.20%)  44 19/385 (4.94%)  21
Investigations     
Creatinine renal clearance decreased  1  32/392 (8.16%)  34 31/385 (8.05%)  36
Weight decreased  1  45/392 (11.48%)  47 50/385 (12.99%)  51
Metabolism and nutrition disorders     
Anorexia  1  52/392 (13.27%)  63 44/385 (11.43%)  50
Hypokalaemia  1  25/392 (6.38%)  28 14/385 (3.64%)  15
Hypomagnesaemia  1  40/392 (10.20%)  47 29/385 (7.53%)  30
Hyponatraemia  1  21/392 (5.36%)  27 24/385 (6.23%)  25
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumour pain  1  23/392 (5.87%)  25 23/385 (5.97%)  26
Psychiatric disorders     
Insomnia  1  23/392 (5.87%)  24 23/385 (5.97%)  23
Respiratory, thoracic and mediastinal disorders     
Cough  1  23/392 (5.87%)  25 20/385 (5.19%)  21
Dyspnoea  1  18/392 (4.59%)  19 21/385 (5.45%)  21
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00415194     History of Changes
Other Study ID Numbers: 8431
H3E-MC-JMHR ( Other Identifier: Eli Lilly and Company )
First Submitted: December 20, 2006
First Posted: December 22, 2006
Results First Submitted: March 10, 2011
Results First Posted: April 6, 2011
Last Update Posted: June 28, 2011